Brand Name

    US Brand Name

    R-Gene 10


    Description

    Arginine injection is used to assess the function of the pituitary gland. It stimulates the pituitary gland to produce growth hormone for the diagnosis of certain conditions.

    This medicine is to be given only by or under the direct supervision of your doctor.

    This product is available in the following dosage forms:

    • Solution

    Before Using

    In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    No information is available on whether the risk of arginine-induced adverse effects is increased in children. However, because of this medication's toxicity, it should be used with extreme caution. Recommended doses should not be exceeded, and the patient should be carefully monitored during treatment.

    Geriatric

    Although appropriate studies on the relationship of age to the effects of arginine injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this diagnostic test, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Receiving this diagnostic test with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Amiloride
    • Spironolactone
    • Triamterene

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

    • Electrolyte imbalance—Should be corrected first before receiving this medicine.
    • Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

    Proper Use

    A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. It must be given slowly, so the needle must stay in place for at least 30 minutes.

    The test is usually given in the morning, after at least 30 minutes of bed rest. You will be advised not to take any food or water the night before the test and during the test procedure. Care should be taken to lessen nervousness and distress, especially in children.

    You may have to repeat this test 1 day after the results of the first one showed a deficiency in the function of your pituitary gland.


    Precautions

    It is very important that your doctor check you closely to make sure that this medicine is working properly and to check for unwanted effects.

    Your growth hormone levels are normally increased when you are pregnant or taking birth control pills, which can affect the result of the test procedure. Talk to your doctor if you have concerns about this before receiving this medicine.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor or nurse immediately if any of the following side effects occur:

    Rare

    • Redness or discoloration of the skin
    • swelling of the hands and face

    Incidence not known

    • Blood in the urine
    • cough
    • difficulty swallowing
    • dizziness
    • fast heartbeat
    • hives, itching, skin rash
    • pain or redness at the injection site
    • pale skin at the injection site
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • tightness in the chest
    • unusual tiredness or weakness

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Confusion
    • deep or fast breathing with dizziness
    • drowsiness
    • muscle tremors
    • numbness of the feet, hands, and around the mouth
    • rapid, deep breathing
    • restlessness
    • stomach cramps

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Less common

    • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, rash, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
    • headache
    • nausea
    • numbness
    • vomiting

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






    CON-XXXXXXXX

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